a study comparing teclistamab monotherapy versus pomalidomide, bortezomib, dexamethasone (pvd) or carfilzomib, dexamethasone (kd) in participants with relapsed or refractory multiple myeloma

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: the purpose of this study is to compare the efficacy of teclistamab with pvd/kd in part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in part 2 in participants with relapsed or refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * documented diagnosis of multiple myeloma as defined by the criteria below: (a)multiple myeloma diagnosis according to international myeloma working group (imwg) diagnostic criteria (b) measurable disease at screening as defined by any of the following: (1) serum m-protein level greater than or equal to (\>=)0.5 grams per deciliter (g/dl) (central laboratory); or (2) urine m-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dl) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio * received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (cd38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line * documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by international myeloma working group (imwg) criteria * have an eastern cooperative oncology group (ecog) performance status score of 0 to 2 * a female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment * must be willing and able to adhere to the lifestyle restrictions specified in this protocol exclusion criteria: * received any prior b cell maturation antigen (bcma)-directed therapy * a participant is not eligible to receive pvd as control therapy if any of the following are present: (1) received prior pomalidomide therapy, (2) does not meet criteria for bortezomib retreatment (3) contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) grade 1 peripheral neuropathy with pain or grade greater than or equal to (\>=) 2 peripheral neuropathy as defined by national cancer institute common terminology criteria for adverse events (nci-ctcae) version 5.0, (5) received a strong cytochrome p (cyp) 3a4 inducer within 5 half-lives prior to randomization; a participant is not eligible to receive kd as control therapy if any of the following are present:(1) received prior carfilzomib therapy, (2) uncontrolled hypertension, defined as an average systolic blood pressure greater than (\>)159 millimeters of mercury (mmhg) or diastolic blood pressure \>99 mmhg despite optimal treatment (3) grade 2 peripheral neuropathy with pain or grade \>=3 peripheral neuropathy as defined by nci-ctcae version 5.0, (4) contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event \[ae\] related to carfilzomib) * received a maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14 days prior to randomization * received a live, attenuated vaccine within 4 weeks before randomization * central nervous system (cns) involvement or clinical signs of meningeal involvement of multiple myeloma * plasma cell leukemia at the time of screening, waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, m-protein (poems) syndrome and skin changes, or primary amyloid light chain amyloidosis